(49 days)
Not Found
Not Found
No
The provided 510(k) summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The provided information does not describe the device, its function, or its intended use beyond referencing "indications for use stated in the enclosure," which is not provided. Without this information, it's impossible to determine if it's a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device has "indications for use," which is characteristic of diagnostic devices that are intended to identify or characterize medical conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is incomplete. It only states "for the indications for use stated in the enclosure," but the enclosure itself is not provided. The intended use is the primary factor in determining if a device is an IVD. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without knowing the specific indications, we cannot assess if it fits this definition.
- Many key sections that would typically provide clues about an IVD are "Not Found". This includes:
- Device Description
- Mentions image processing (while not exclusive to IVDs, it's common in some)
- Mentions AI, DNN, or ML (increasingly used in IVDs)
- Input Imaging Modality (IVDs often process data from specific modalities)
- Anatomical Site (IVDs often relate to specific body systems or samples)
- Indicated Patient Age Range (can be relevant for IVDs)
- Intended User / Care Setting (IVDs are often used in labs or clinical settings)
- Description of training/test sets and performance studies (crucial for demonstrating the analytical and clinical performance of an IVD)
- Key Metrics (Sensitivity, Specificity, etc. are standard performance metrics for IVDs)
The only potentially relevant information is the mention of "legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... or to devices that have been reclassified". This suggests the device is being compared to existing medical devices, but it doesn't specifically indicate whether those predicates were IVDs.
In conclusion, without the specific "Indications for Use" and more details about the device's function and how it is used, we cannot confirm if it is an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
LLL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
Re: K990797 Trade Name: Autostat™ II Anti-Scl-70 ELISA Regulatory Class: II Product Code: LLL Dated: February 16, 1999 Received: March 10, 1999
Dear Ms. Knight:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. E.J.Smith
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure